For Pfizer and BioNTech’s Comirnaty, the CHMP has approved Delpharm’s Saint Rémy sur Avre site in France. The facility will manufacture finished product, and is set to provide around 51 million additional doses this year.
A new manufacturing line at BioNTech’s Marburg manufacturing site has also been approved, increasing active substance manufacturing capacity by around 410 million doses this year.
For Moderna’s Spikevax, the CHMP has approved Catalent’s Bloomington, Indiana, US site: which will perform finished product manufacturing. It has also approved several alternative sites responsible for batch control/testing and packaging of the finished product manufactured by Catalent.
Scale-up of the active substance manufacturing process at two sites in the US (Moderna TX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire) were already given the green light on July 30. All together, these approvals will allow the production of 40 million additional doses of Spikevax destined for the EU market in the third quarter of 2021.